Posting: # 18062
I want to know if there is any guidelines that talked about what to do if whole one period concentrations (Test or Reference) was zero.
I know statistically that in such case, the whole period or subject is deleted. But I am looking for a reference or guidelines for that.
I know that there is a guidelines talking about the reference and also the test in very low conc. However, my case is that the test is Zero not very low conc.
@ Mohamed Yehia
Posting: # 18063
Tricky question. The concentrations are not 0, they are just under the LLOQ, so you may impute the values as missing, 0 or 1/2 of the LLOQ. Therefore, depending on the method, you would be able to use the subject in the statistical analysis at least for Cmax and AUC0-t. But I think it's a bit odd. Would be very glad to know what the experts of the forum think about this subject. I imagine that such an occurrence might be very rare and should be further explored with the clinical team (for instance, have the subject really taken the pills?). If I was responsible for reviewing the dossier for this study, I would surely recommend an inspection